Salazopyrin

When are you taking this medicine? Empty stomach Before food After food With a meal

Salazopyrin uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• References
• Salazopyrin reviews

INDICATIONS AND USAGE

Salazopyrin tablets, USP are indicated:

• in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
• for the prolongation of the remission period between acute attacks of ulcerative colitis.

CONTRAINDICATIONS

Salazopyrin tablets are contraindicated in:

• Patients with intestinal or urinary obstruction,
• Patients with porphyria as sulfonamides have been reported to precipitate an acute attack,
• Patients hypersensitive to Salazopyrin, its metabolites, sulfonamides, or salicylates.

WARNINGS

Only after critical appraisal should Salazopyrin tablets be given to patients with hepatic or renal damage or blood dyscrasias. Deaths associated with the administration of Salazopyrin have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis. The presence of clinical signs such as sore throat, fever, pallor, purpura, or jaundice may be indications of serious blood disorders or hepatotoxicity. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving Salazopyrin (see PRECAUTIONS, Laboratory Tests ). Discontinue treatment with Salazopyrin while awaiting the results of blood tests. Oligospermia and infertility have been observed in men treated with Salazopyrin; however, withdrawal of the drug appears to reverse these effects.

Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. Discontinue Salazopyrin if a patient develops a serious infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Salazopyrin. For a patient who develops a new infection during treatment with Salazopyrin, perform a prompt and complete diagnostic workup for infection and myelosuppression. Caution should be exercised when considering the use of Salazopyrin in patients with a history of recurring or chronic infections or with underlying conditions or concomitant drugs which may predispose patients to infections.

Severe hypersensitivity reactions may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (i.e., pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of Salazopyrin. Patients are at highest risk for these events early in therapy, with most events occurring within the first month of treatment. Salazopyrin should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and

systemic symptoms have been reported in patients taking Salazopyrin. Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Salazopyrin should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

PRECAUTIONS

General:

Salazopyrin tablets should be given with caution to patients with severe allergy or bronchial asthma. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation. Patients with glucose-6 phosphate dehydrogenase deficiency should be observed closely for signs of hemolytic anemia. This reaction is frequently dose related. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately.

Information for Patients:

Patients should be informed of the possibility of adverse reactions and of the need for careful medical supervision. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Should any of these occur, the patient should seek medical advice. They should also be made aware that ulcerative colitis rarely remits completely, and that the risk of relapse can be reduced by continued administration of Salazopyrin at a maintenance dosage. Patients should be instructed to take Salazopyrin in evenly divided doses preferably after meals. Additionally, patients should be advised that Salazopyrin may produce an orange-yellow discoloration of the urine or skin.

Laboratory Tests:

Complete blood counts, including differential white cell count and liver function tests, should be performed before starting Salazopyrin and every second week during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Urinalysis and an assessment of renal function should also be done periodically during treatment with Salazopyrin.

The determination of serum sulfapyridine levels may be useful since concentrations greater than 50 mcg/mL appear to be associated with an increased incidence of adverse reactions.

Drug Interactions:

Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with Salazopyrin.

Drug/Laboratory Test Interactions:

Several reports of possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to Salazopyrin or its metabolite, mesalamine/mesalazine.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Two-year oral carcinogenicity studies were conducted in male and female F344/N rats and B6C3F1 mice. Salazopyrin was tested at 84, 168 (991 mg/m ²), and 337.5 (1991 mg/m ²) mg/kg/day doses in rats. A statistically significant increase in the incidence of urinary bladder transitional cell papillomas was observed in male rats. In female rats, two (4%) of the 337.5 mg/kg rats had transitional cell papilloma of the kidney. The increased incidence of neoplasms in the urinary bladder and kidney of rats was also associated with an increase in the renal calculi formation and hyperplasia of transitional cell epithelium. For the mouse study, Salazopyrin was tested at 675 (2025 mg/m ²), 1350 (4050 mg/m ²), and 2700 (8100 mg/m ²) mg/kg/day. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested.

Salazopyrin did not show mutagenicity in the bacterial reverse mutation assay (Ames test) and in L51784 mouse lymphoma cell assay at the HGPRT gene. However, Salazopyrin showed equivocal mutagenic response in the micronucleus assay of mouse and rat bone marrow and mouse peripheral RBC and in the sister chromatid exchange, chromosomal aberration, and micronucleus assays in lymphocytes obtained from humans.

Impairment of male fertility was observed in reproductive studies performed in rats at a dose of 800 mg/kg/day (4800 mg/m ²). Oligospermia and infertility have been described in men treated with Salazopyrin. Withdrawal of the drug appears to reverse these effects.

Pregnancy:

Teratogenic Effects:

Pregnancy Category B:

There are no adequate and well-controlled studies of Salazopyrin in pregnant women. Reproduction studies have been performed in rats and rabbits at doses up to 6 times the human maintenance dose of 2 g/day based on body surface area and have revealed no evidence of impaired female fertility or harm to the fetus due to Salazopyrin. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

There have been case reports of neural tube defects in infants born to mothers who were exposed to Salazopyrin during pregnancy, but the role of Salazopyrin in these defects has not been established. However, oral Salazopyrin inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation and diminish the effect of periconceptional folic acid supplementation that has been shown to decrease the risk of NTDs.

A national survey evaluated the outcome of pregnancies associated with inflammatory bowel disease (IBD). In a group of 186 women treated with Salazopyrin alone or Salazopyrin and concomitant steroid therapy, the incidence of fetal morbidity and mortality was comparable to that for 245 untreated IBD pregnancies as well as to pregnancies in the general population. ¹ A study of 1,455 pregnancies associated with exposure to sulfonamides indicated that this group of drugs, including Salazopyrin, did not appear to be associated with fetal malformation. ² A review of the medical literature covering 1,155 pregnancies in women with ulcerative colitis suggested that the outcome was similar to that expected in the general population. ³

No clinical studies have been performed to evaluate the effect of Salazopyrin on the growth development and functional maturation of children whose mothers received the drug during pregnancy.

Clinical Considerations:

Salazopyrin and its metabolite, sulfapyridine, pass through the placenta. Salazopyrin and its metabolite are also present in human milk. In the newborn, sulfonamides compete with bilirubin for binding sites on the plasma proteins and may cause kernicterus. Although sulfapyridine has been shown to have a poor bilirubin-displacing capacity, monitor the newborn for the potential for kernicterus.

A case of agranulocytosis has been reported in an infant whose mother was taking both Salazopyrin and prednisone throughout pregnancy.

Nursing Mothers:

Sulfonamides, including Salazopyrin, are present in human milk. Insignificant amounts of Salazopyrin have been found in milk, whereas levels of the active metabolite sulfapyridine in milk are about 30 to 60 percent of those in the maternal serum. Caution should be exercised when Salazopyrin is administered to a nursing mother.

There are reports with limited data of bloody stools or diarrhea in human milk fed infants of mothers taking Salazopyrin. In cases where the outcome was reported, bloody stools or diarrhea resolved in the infant after discontinuation of Salazopyrin in the mother or discontinuation of breastfeeding. Due to limited data, a causal relationship between Salazopyrin exposure and bloody stools or diarrhea cannot be confirmed or denied. Monitor human milk fed infants of mothers taking Salazopyrin for signs and symptoms of diarrhea and/or bloody stools.

Pediatric Use:

Safety and effectiveness in pediatric patients below the age of two years have not been established.

ADVERSE REACTIONS

The most common adverse reactions associated with Salazopyrin are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. These occur in about one-third of the patients. Less frequent adverse reactions are skin rash, pruritus, urticaria, fever, Heinz body anemia, hemolytic anemia and cyanosis, which may occur at a frequency of one in every thirty patients or less. Experience suggests that with a daily dosage of 4 g or more, or total serum sulfapyridine levels above 50 mcg/mL, the incidence of adverse reactions tends to increase.

Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the sulfonamides require that each of these reactions be considered when Salazopyrin tablets are administered. Less common or rare adverse reactions include:

Blood dyscrasias: aplastic anemia, agranulocytosis, leukopenia, megaloblastic (macrocytic) anemia, purpura, thrombocytopenia, hypoprothrombinemia, methemoglobinemia, congenital neutropenia, and myelodysplastic syndrome.

Hypersensitivity reactions: erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, epidermal necrolysis (Lyell's syndrome) with corneal damage, drug rash with eosinophilia and systemic symptoms (DRESS), anaphylaxis, serum sickness syndrome, interstitial lung disease, pneumonitis with or without eosinophilia, vasculitis, fibrosing alveolitis, pleuritis, pericarditis with or without tamponade, allergic myocarditis, polyarteritis nodosa, lupus erythematosus-like syndrome, hepatitis and hepatic necrosis with or without immune complexes, fulminant hepatitis, sometimes leading to liver transplantation, parapsoriasis varioliformis acuta (Mucha-Haberman syndrome), rhabdomyolysis, photosensitization, arthralgia, periorbital edema, conjunctival and scleral injection, and alopecia.

Gastrointestinal reactions: hepatitis, hepatic failure, pancreatitis, bloody diarrhea, impaired folic acid absorption, impaired digoxin absorption, stomatitis, diarrhea, abdominal pains, and neutropenic enterocolitis.

Central nervous system reactions: transverse myelitis, convulsions, meningitis, transient lesions of the posterior spinal column, cauda equina syndrome, Guillain-Barre syndrome, peripheral neuropathy, mental depression, vertigo, hearing loss, insomnia, ataxia, hallucinations, tinnitus, and drowsiness.

Renal reactions: toxic nephrosis with oliguria and anuria, nephritis, nephrotic syndrome, urinary tract infections, hematuria, crystalluria, proteinuria, and hemolytic-uremic syndrome.

Other reactions: urine discoloration and skin discoloration.

The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in this species.

Postmarketing Reports

The following events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:

Blood dyscrasias: pseudomononucleosis

Cardiac disorders: myocarditis

Hepatobiliary disorders: reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatitis cholestatic, cholestasis and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported.

Immune system disorders: anaphylaxis

Metabolism and nutrition system disorders: folate deficiency

Renal and urinary disorders: nephrolithiasis

Respiratory, thoracic and mediastinal disorders: oropharyngeal pain

Skin and subcutaneous tissue disorders: angioedema, purpura

Vascular disorders: pallor

DRUG ABUSE AND DEPENDENCE

None reported.

OVERDOSAGE

There is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration. Symptoms of overdosage may include nausea, vomiting, gastric distress, and abdominal pains. In more advanced cases, central nervous system symptoms such as drowsiness, convulsions, etc., may be observed. Serum sulfapyridine concentrations may be used to monitor the progress of recovery from overdosage.

There are no documented reports of deaths due to ingestion of large single doses of Salazopyrin. Doses of Salazopyrin tablets of 16 g per day have been given to patients without mortality. A single oral dose of 12 g/kg was not lethal to mice.

Instructions for Overdosage:

Gastric lavage or emesis plus catharsis as indicated. Alkalinize urine. If kidney function is normal, force fluids. If anuria is present, restrict fluids and salt, and treat appropriately. Catheterization of the ureters may be indicated for complete renal blockage by crystals. The low molecular weight of Salazopyrin and its metabolites may facilitate their removal by dialysis.

DOSAGE AND ADMINISTRATION

The dosage of Salazopyrin tablets should be adjusted to each individual's response and tolerance.

Initial Therapy:

Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. In some cases, it is advisable to initiate therapy with a smaller dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind.

Children, six years of age and older: 40 to 60 mg/kg body weight in each 24-hour period, divided into 3 to 6 doses.

Maintenance Therapy:

Adults: 2 g daily.

Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses.

The response of acute ulcerative colitis to Salazopyrin tablets can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. When endoscopic examination confirms satisfactory improvement, the dosage of Salazopyrin should be reduced to a maintenance level. If diarrhea recurs, the dosage should be increased to previously effective levels. If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of Salazopyrin, they are probably due to increased serum levels of total sulfapyridine and may be alleviated by halving the daily dose of Salazopyrin and subsequently increasing it gradually over several days. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose.

Some patients may be sensitive to treatment with Salazopyrin. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients, ⁴ 7 of 8 patients, ⁵ and 19 of 20 patients. ⁶ These regimens suggest starting with a total daily dose of 50 to 250 mg Salazopyrin initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. If the symptoms of sensitivity recur, Salazopyrin should be discontinued. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving Salazopyrin.

HOW SUPPLIED

Salazopyrin Tablets USP, 500 mg are round, gold-colored, scored tablets, debossed "5904" and "V" on one side and plain on the reverse side. They are available in the following package sizes:

• Bottles of 40 tablets

Storage:

Store at 20° to 25°C (68° to 77°F).

REFERENCES

• Mogadam M, et al. Pregnancy in inflammatory bowel disease: effect of Salazopyrin and corticosteroids on fetal outcome. Gastroenterology 1981;80:72–6.
• Kaufman DW, editor. Birth defects and drugs during pregnancy. Littleton, MA: Publishing Sciences Group, Inc., 1977: 296–313.
• Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. Scand J Gastroenterol 1982;17:1–4.
• Korelitz B, et al. Desensitization to Salazopyrin in allergic patients with IBD: an important therapeutic modality. Gastroenterology 1982;82:1104.
• Holdworth CG. Sulphasalazine desensitization. Br Med J 1981;282:110.
• Taffet SL, Das KM. Desensitization of patients with inflammatory bowel disease to Salazopyrin. Am J Med 1982;73:520–4.

Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8181485

Rev 3/14

R7

Salazopyrin pharmaceutical active ingredients containing related brand and generic drugs:

• Sulfasalazine

Salazopyrin available forms, composition, doses:

• SALAZOPYRIN 500MG EN-TABLET
• SALAZOPYRIN 500MG TABLET
• Suppositories; Rectal; Sulfasalazine 500 mg
• Suspension; Oral; Sulfasalazine 250 mg / 5 ml
• Tablets; Oral; Sulfasalazine 500 mg

Salazopyrin destination | category:

• Human:
• Disease-modifying anti-rheumatic drugs (DMARDs)
• GIT regulators, antiflatulents and anti-inflammatories
• Sulfonamides

Salazopyrin Anatomical Therapeutic Chemical codes:

• A07EC01 - Sulfasalazine

Salazopyrin pharmaceutical companies:

• Perrigo
• Pfizer

References

1. Dailymed."SULFASALAZINE TABLET [PD-RX PHARMACEUTICALS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."SULFASALAZINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "sulfasalazine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Salazopyrin?

Depending on the reaction of the Salazopyrin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Salazopyrin not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Salazopyrin addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Salazopyrin, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Salazopyrin consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reviews

There are no reviews yet. Be the first to write one!

Your name:  Email:  Spam protection:  < Type 23 here

The information was verified by Dr. Rachana Salvi, MD Pharmacology